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Monoclonal Antibodies

Atezolizumab Trial in Endometrial Cancer - AtTEnd (AtTEnd Trial)

Seoul, Korea, Republic of
Phase 3
Waitlist Available
Led By Nicoletta Colombo, MD
Research Sponsored by Mario Negri Institute for Pharmacological Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after the end of treatment
Awards & highlights
Pivotal Trial

Summary

Atezolizumab is an engineered humanised monoclonal immunoglobulin G1 antibody that binds selectively to PD-L1 and prevents its interaction with PD-1 and B7-1. In May 2016 atezolizumab was approved by the FDA for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant); in October 2016 it was approved by the FDA for patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities. Finally, in April 2017 atezolizumab was granted accelerated approval by FDA for the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy. Combinations of atezolizumab with chemotherapeutic agents and/or targeted therapies were studied in different solid tumors such as melanoma, NSCLC, renal cell carcinoma and colorectal carcinoma. From these studies the AE profile of atezolizumab combinations were consistent with that of the individual agents. Finally, preliminary results of a Phase Ia study of Atezolizumab (NCT01375842) monotherapy in relapsed endometrial cancer were reported as abstract at ASCO 2017. Fifteen patients were evaluated for safety and efficacy with a minimum follow-up of 11.2 months. No G4-5 related AEs occurred. Regarding efficacy ORR was 13% \[2/15\] by RECIST. Atezolizumab seemed to have a favorable safety profile, with durable clinical benefit in some patients. Further studies with atezolizumab are warranted given its promising results in advanced endometrial cancer and the limited efficacy of current treatment options.

Eligible Conditions
  • Endometrial Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after the end of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after the end of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
OS
PFS
PFS in the MSI
Secondary study objectives
Compliance: Dose intensity
Compliance: Number of administered cycles
Compliance: Reasons for discontinuation and treatment modification
+11 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental armExperimental Treatment3 Interventions
paclitaxel 175 mg/m2 + carboplatin AUC 5 or 6 will be administered every 21 days for 6-8 cycles or PD. Atezolizumab will be administered as I.V. infusion at a fixed dose of 1200 mg, every 21 days until objective radiological disease progression as assessed by the investigator if they do not meet any other discontinuation criteria (patient refusal, toxicity). Patients who are clinically stable at initial RECIST v 1.1 - defined progression - should continue on treatment until the next imaging assessment that should be ≥4 weeks and no longer than 8 weeks later.
Group II: Control armPlacebo Group3 Interventions
paclitaxel 175 mg/m2 + carboplatin AUC 5 or AUC 6 will be administered every 21 days for 6-8 cycles or PD. Placebo will be administered as I.V. infusion every 21 days until objective radiological disease progression as assessed by the investigator if they do not meet any other discontinuation criteria (patient refusal, toxicity). Patients who are clinically stable at initial RECIST v 1.1 - defined progression - should continue on treatment until the next imaging assessment that should be ≥4 weeks and no longer than 8 weeks later.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2016
Completed Phase 3
~5860
Paclitaxel
2011
Completed Phase 4
~5450
Carboplatin
2014
Completed Phase 3
~6450

Find a Location

Who is running the clinical trial?

Mario Negri Institute for Pharmacological ResearchLead Sponsor
172 Previous Clinical Trials
1,022,083 Total Patients Enrolled
1 Trials studying Endometrial Cancer
670 Patients Enrolled for Endometrial Cancer
Hoffmann-La RocheIndustry Sponsor
2,481 Previous Clinical Trials
1,106,616 Total Patients Enrolled
1 Trials studying Endometrial Cancer
30 Patients Enrolled for Endometrial Cancer
Nicoletta Colombo, MDPrincipal InvestigatorIstituto Europeo di Oncologia (IEO) - Milan
4 Previous Clinical Trials
2,946 Total Patients Enrolled
~74 spots leftby Mar 2026